We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Active Living Every Day Exercise Program for People With Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146367
First Posted: September 7, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of North Carolina
Information provided by:
Centers for Disease Control and Prevention
  Purpose
The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.

Condition Intervention Phase
Arthritis Behavioral: Active Living Every Day Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Health Benefits of the Active Living Every Day Physical Activity Program Among Persons With Arthritis

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks
  • Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks

Secondary Outcome Measures:
  • Functional status measured via HAQ at baseline and 20 weeks
  • Arthritis Self-efficacy measured at baseline and 20 weeks
  • Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months
  • Pain, fatigue and stiffness VAS at baseline and 20 weeks
  • Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months

Estimated Enrollment: 355
Study Start Date: January 2004
Estimated Study Completion Date: October 2005
Detailed Description:

Evidence has shown that regular moderate-intensity physical activity improves symptoms and function in persons with arthritis. A 20-week behavior-based program was developed by the Cooper Institute, Brown University, and Human Kinetics to help people with sedentary lifestyles become and stay physically active. A randomized trial evaluated the effectiveness and efficacy of a similar program on which Active Living Every Day is based (ALED) on cardiovascular disease risk factors, cost-effectiveness, and cardiorespiratory fitness. However, the current research supporting ALED is limited for people with arthritis. The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. The primary goal will be accomplished through a twenty week randomized controlled trial conducted with 400 participants residing in the 17 Area Agencies on Aging housed in the Councils of Government in North Carolina, including both urban and rural counties. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.

Objectives:

  1. To demonstrate that the ALED program can increase physical activity and fitness levels among people with arthritis.
  2. To demonstrate that the Active Living Every Day has arthritis-specific benefits.
  3. To evaluate the feasibility of disseminating the Active Living Every Day program through the NC public health network.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-reported arthritis or chronic joint symptoms
  • Currently exercising less than 3 times per week
  • Plan to be in community for at least 1 year
  • Physician release for participation in physical activity

Exclusion Criteria:

  • Pregnancy
  • Non-English speaking
  • Cognitive impairment
  • Serious medical condition where exercise is contradindicated
  • Severe physical or mental impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146367


Sponsors and Collaborators
Centers for Disease Control and Prevention
University of North Carolina
Investigators
Study Chair: Jennifer M Hootman, PhD Centers for Disease Control and Prevention
Principal Investigator: Leigh F Callahan, PhD University of North Carolina, Chapel Hill
  More Information

ClinicalTrials.gov Identifier: NCT00146367     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-0444
CDC-NCCDPHP-MM-0444
First Submitted: September 2, 2005
First Posted: September 7, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Centers for Disease Control and Prevention:
arthritis
osteoarthritis
rheumatoid arthritis
rheumatic disease
exercise
physical activity
physical function
disability

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases